Characterization of Skin Changes (Clinical, Physiological and Pathological) Leading to Dermatological Adverse Events From Chemotherapy, Targeted Therapy, Hormonal Therapy, and Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Skin Dryness Severity
研究概览
简要总结
The goal of this clinical trial is to evaluate whether cosmeceutical topical moisturizers can help with skin dryness in participants with cancer experiencing a dermatological adverse event from cancer therapies. The main question it aims to answer is:
Does cosmeceutical topical moisturizers help with skin dryness?
Participants will:
- Visit the clinic for a baseline visit to complete skin evaluation and tests.
- Apply cosmeceutical topical moisturizers daily from baseline up until the follow-up visit.
- Visit the clinic for a follow-up visit (approximately 2-4 weeks from baseline) for a repeat skin evaluation and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (18 years or older).
- •Patients diagnosed with cancer.
- •Patient receiving cancer treatment or therapy (receiving chemotherapy, targeted treatment, hormonal therapy, and/or immune checkpoint inhibitors).
- •Patient experiencing a dermatological adverse event from a cancer treatment or therapy.
排除标准
- •Patient is unable to understand scope of the study.
- •Patient is unable to provide written informed consent.
- •Patient is healthy.
研究组 & 干预措施
Moisturizer
Participants in this arm will apply the following cosmeceutical topical moisturizers twice daily (once in the morning and once in the evening) for the duration of the study:
- La Roche Posay Lipikar wash Atopy-Prone Plus (AP+) moisturizing face and body wash (once in the morning and once in the evening)
- La Roche Posay Lipikar AP+ triple repair moisturizing cream (once in the morning and once in the evening)
- La Roche Posay Cicaplast balm Panthenol/Vitamin B5 (B5+) (once in the morning and once in the evening)
干预措施: La Roche Posay Lipikar Wash Atopy-Prone Plus (AP+) Moisturizing Face and Body Wash (Other)
Moisturizer
Participants in this arm will apply the following cosmeceutical topical moisturizers twice daily (once in the morning and once in the evening) for the duration of the study:
- La Roche Posay Lipikar wash Atopy-Prone Plus (AP+) moisturizing face and body wash (once in the morning and once in the evening)
- La Roche Posay Lipikar AP+ triple repair moisturizing cream (once in the morning and once in the evening)
- La Roche Posay Cicaplast balm Panthenol/Vitamin B5 (B5+) (once in the morning and once in the evening)
干预措施: La Roche Posay Lipikar AP+ Triple Repair Moisturizing Cream (Other)
Moisturizer
Participants in this arm will apply the following cosmeceutical topical moisturizers twice daily (once in the morning and once in the evening) for the duration of the study:
- La Roche Posay Lipikar wash Atopy-Prone Plus (AP+) moisturizing face and body wash (once in the morning and once in the evening)
- La Roche Posay Lipikar AP+ triple repair moisturizing cream (once in the morning and once in the evening)
- La Roche Posay Cicaplast balm Panthenol/Vitamin B5 (B5+) (once in the morning and once in the evening)
干预措施: La Roche Posay Cicaplast balm Panthenol/Vitamin B5 (B5+) (Other)
结局指标
主要结局
Change in Patient-Reported Skin Dryness Severity
时间窗: From baseline visit to follow-up visit (approximately 2-4 weeks).
Change in patient-reported skin dryness severity from baseline to follow-up visit (2-4 weeks) as measured by validated dryness severity scale (0-10 numerical rating scale where 0 = no dryness and 10 = severe dryness).
次要结局
- Time to improvement in dryness symptoms(From baseline visit to follow-up visit (2-4 weeks).)
- Change in Stratum Corneum Hydration(From baseline visit to follow-up visit (2-4 weeks).)
- Change in Transepidermal Water Loss (TEWL)(From baseline visit to follow-up visit (2-4 weeks).)